Data Coordinator - DM

Overview

Data Coordinator - DM role in the Clinical Data Sciences team, supporting biotech, medtech, and specialty pharma clients with clinical data management.

What you'll do

• Prepare documentation such as CCGs, Data Management Plan (DMP), Data Report Specifications, and External Data Transfer Specifications.
• Assist in developing standard test data for testing screens and listings and provide feedback on testing results.
• Perform user acceptance testing on studies, including testing of edit checks.
• Assist in maintaining databases and support database updates.
• Perform data entry.
• Generate reports for data review.
• Review CRFs, data listings, and databases to ensure captured data follows protocol, CCGs, and DMP.
• Generate queries to appropriate internal or external personnel (e.g., investigational sites, Clinical Research Associates and client representatives) to resolve problematic data.
• Review query responses and resolve discrepancies.
• Perform external data and/or serious adverse event reconciliation.
• Act as Lead Data Coordinator and/or Safety Reviewer on multiple studies.
• Perform document submission to the Trial Master File (TMF) and support TMF Quality Control (QC) activities.
• Perform database QC activities and QC of study reports and CRF archive files.
• Support the Data Scientist and/or PM in reporting financial project stats, study metrics, dashboard updates, and project status.

What you'll need

• Bachelor's Degree or above.
• Typically requires 2 - 4 years of DM mastery or related clinical research industry experience.
• Knowledge of at least one Clinical Data Management System (CDMS) (e.g., Medidata Rave, Calyx EDC).

Nice to have

• Degree preferably in a Life Science.

Details

• Hybrid role based out of the Bangalore office.